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Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy (PCV)

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ClinicalTrials.gov Identifier: NCT03929731
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gemmy Cheung Chui Ming, Singapore National Eye Centre

Brief Summary:
To determine long-term outcomes, recurrence rates, and treatment needs in Polypoidal Choroidal Vasculopathy (PCV). Specifically, to describe the long-term outcomes, recurrence rates and treatment patterns PCV patients 5 years after first presentation. This study will also evaluate whether polyp closure within the first 12 months of therapy is associated with better long-term visual outcome and will also determine the risk of disease development in the fellow eye

Condition or disease Intervention/treatment
Polypoidal Choroidal Vasculopathy Diagnostic Test: Indocyanine Green Angiography

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Determine Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy(PCV)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Polypoidal Choroidal Vasculopathy RCT
Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies
Diagnostic Test: Indocyanine Green Angiography
Intravenous injection of dye-indocyanine green
Other Names:
  • Optical Coherence Tomography-Angiography
  • Fundus photography
  • Fundus fluorescein
  • Optical Coherence Tomography




Primary Outcome Measures :
  1. Long term prognostication [ Time Frame: within 72 months ]
    Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies
Criteria

Inclusion Criteria:

  • Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies
  • Are able to give consent for this follow up study

Exclusion Criteria:

  • No exclusion criteria unless they do not meet the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929731


Contacts
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Contact: Principal Investigator 63227460 gemmy.cheung.c.m@singhealth.com.sg
Contact: co-Investigator 63228378 kelvin.teo.y.c@singhealth.com.sg

Locations
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Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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Principal Investigator: Principal Investigator Singapore National Eye Centre

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Responsible Party: Gemmy Cheung Chui Ming, Assistant Professor, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT03929731     History of Changes
Other Study ID Numbers: R1597/96/2018
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Recurrence
Vascular Diseases
Disease Attributes
Pathologic Processes
Cardiovascular Diseases